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Avanos Medical has recalled Cortrak*2 EAS because of reports of injuries and deaths due to tube misplacements.
feeding tube placement The US Food and Drug Administration has confirmed Avanos Medical's Cortrak*2 enal Access System Recall (EAS) in a Class I recall.
A Class I recall is the most serious one out of three classes.
Avanos Medical Avanos Medical recalls Cortrak*2 EAS after reports of injury and even death caused by the wrong placement of nasogastric and nasoenteric tubes.
The device allows healthcare personnel to place medical feeding tubes inside patients.
Avanos Medical feeding tube However, the wrong positioning of nasogastric or nasal tubes could cause damage to a patient's vocal cords, lungs or trachea and cause severe injuries or even death.
The recall covers 629 devices that were sold in the US between February 1st, 2016 and 1 January 2022.
According to the recall notice, the company stated that in the year 2015, there have been more than 60 injuries and 23 deaths as a result of the misplacement or the use of a Nasogastric feeding tubes while making use of the Cortrak* 2 EAS.
http://spectr-sb116.ru/user/Avanos.Mediacal.Cortrak.2vema653/ Avanos Medical will revise the labelling after the recall. This will include updated instructions on how to use the device and the intended use of the Cortrak*2 EAS.
The new guidelines direct users to verify that the tube is set up according to the protocol of the institution before to its use.
Avanos Medical is based in Alpharetta (Georgia) in the United States. Avanos Medical It specializes in the production of medical devices. Avanos Medical The company sells its recognized brands across more than 90 countries.
The company entered into a $160m contract in December last year to purchase OrthogenRx. Avanos Medical concluded the acquisition on 20th January.
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